Committees of ethics in research: from technical and scientific language to normatization

Detalhes bibliográficos
Autor(a) principal: Thomasi, Tanise Zago
Data de Publicação: 2016
Tipo de documento: Artigo
Idioma: por
Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/299
Resumo: The aim of this article is to discuss the role of the Ethics in Research and its responsibility for the adoption of future health policies. First, we present the institutional, functional and organizational characteristics of the system CEP / CONEP established by Resolution no. 196/1996 CNS and subsequently the changes suffered as a result of the approval of Resolution no. 466/2012 and no. 510/2016 also from CNS and its national influences. To this end, we investigate its legal guidelines, combined with the Single Health System (SUS), evaluating the use of technical-scientific language. Finally, the importance of including expert opinions on research involving human subjects, as those responsible for the affirmation of brazilian health law, analyzing the controversial court case involving the local population of Amapá state, which has become known as "human guinea pigs". We concluded, following which the Research Ethics Committee is the organization responsible for the future of the health system, precisely by established institutional communications when the authorization of such studies involving human subjects.
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spelling Committees of ethics in research: from technical and scientific language to normatizationComités de ética en la investigación: desde el lenguaje técnico y científico hasta la normalizaciónComitês de Ética em Pesquisa: da Linguagem Técnico-Cientifica à NormatizaçãopesquisaResearch Ethics Comitees. Humans Being. Research. ResolutionsComités de Ética de la Investigación. Los Seres Humanos. Investigación. Resoluciones.The aim of this article is to discuss the role of the Ethics in Research and its responsibility for the adoption of future health policies. First, we present the institutional, functional and organizational characteristics of the system CEP / CONEP established by Resolution no. 196/1996 CNS and subsequently the changes suffered as a result of the approval of Resolution no. 466/2012 and no. 510/2016 also from CNS and its national influences. To this end, we investigate its legal guidelines, combined with the Single Health System (SUS), evaluating the use of technical-scientific language. Finally, the importance of including expert opinions on research involving human subjects, as those responsible for the affirmation of brazilian health law, analyzing the controversial court case involving the local population of Amapá state, which has become known as "human guinea pigs". We concluded, following which the Research Ethics Committee is the organization responsible for the future of the health system, precisely by established institutional communications when the authorization of such studies involving human subjects.El objetivo de este artículo es analizar el desempeño de los comités de ética de la investigación y su responsabilidad en la adopción de las futuras políticas públicas. Presentamos el relator institucional, funcional y organizacional del sistema CEP/CONEP impuesta por la Resolución n° 196/1996 de el Consejo Nacional de Salud y los cambios debidos a la aprobación de las resoluciones n°. 466/2012 y 510/2016 del CNS y sus influencias nacionales. Para ello, investigamos las directrices legales, con el Sistema Unificado de Salud (SUS), evaluando el uso de la ciencia de la lengua. Por fin, hay discusión sobre la importancia del asesoramiento técnico sobre la investigación en seres humanos, tales como los responsables de la afirmación del derecho a la salud en Brasil, analizando el corte polémico caso que involucra a la población pobre del estado de Amapá, que llegó a ser conocido como "conejillos de indias" humanos. Concluimos que los comités de ética en la investigación es la organización responsable para el futuro del sistema de salud, necesitamos de comunicaciones institucionales establecidas cuando la autorización de la culminación de los estudios con seres humanos.O objetivo desse artigo é discutir a atuação dos Comitês de Ética em Pesquisa e sua responsabilidade pela adoção de futuras políticas públicas sanitárias. Primeiro, apresentamos as particularidades institucionais, funcionais e organizacionais do Sistema CEP/CONEP instituídas pela Resolução n. 196/1996 do CNS e posteriormente as alterações sofridas em decorrência da aprovação da Resolução n. 466/2012 também do CNS e suas influências nacionais. Para tanto, investigamos suas diretrizes legais, aliadas ao Sistema Único de Saúde –SUS, avaliando o emprego da linguagem técnico-científica. Finalmente, polemizamos a importância da emissão de pareceres técnicos sobre a pesquisa envolvendo seres humanos, como os responsáveis pela afirmação do direito sanitário brasileiro, analisando o polêmico processo judicial envolvendo a população ribeirinha do estado do Amapá, que passou a ser conhecido como “cobaias humanas”. Concluímos, na sequência, que os Comitês de Ética em Pesquisa é a organização responsável pelo futuro do sistema saúde, justamente, pelas comunicações institucionais estabelecidas quando da autorização da realização dos estudos envolvendo seres humanos.Fundação Oswaldo Cruz Brasília2016-09-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/29910.17566/ciads.v5i3.299Iberoamerican Journal of Health Law; Vol. 5 No. 3 (2016): (JUL/SET.2016); 10-30Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 5 Núm. 3 (2016): (JUL/SET.2016); 10-30Cadernos Ibero-Americanos de Direito Sanitário; v. 5 n. 3 (2016): (JUL/SET.2016); 10-302358-18242317-839610.17566/ciads.v5i3reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/299/393Copyright (c) 2016 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIOinfo:eu-repo/semantics/openAccessThomasi, Tanise Zago2016-12-13T16:29:27Zoai:ojs.cadernos.prodisa.fiocruz.br:article/299Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2016-12-13T16:29:27Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Committees of ethics in research: from technical and scientific language to normatization
Comités de ética en la investigación: desde el lenguaje técnico y científico hasta la normalización
Comitês de Ética em Pesquisa: da Linguagem Técnico-Cientifica à Normatização
title Committees of ethics in research: from technical and scientific language to normatization
spellingShingle Committees of ethics in research: from technical and scientific language to normatization
Thomasi, Tanise Zago
pesquisa
Research Ethics Comitees. Humans Being. Research. Resolutions
Comités de Ética de la Investigación. Los Seres Humanos. Investigación. Resoluciones.
title_short Committees of ethics in research: from technical and scientific language to normatization
title_full Committees of ethics in research: from technical and scientific language to normatization
title_fullStr Committees of ethics in research: from technical and scientific language to normatization
title_full_unstemmed Committees of ethics in research: from technical and scientific language to normatization
title_sort Committees of ethics in research: from technical and scientific language to normatization
author Thomasi, Tanise Zago
author_facet Thomasi, Tanise Zago
author_role author
dc.contributor.author.fl_str_mv Thomasi, Tanise Zago
dc.subject.por.fl_str_mv pesquisa
Research Ethics Comitees. Humans Being. Research. Resolutions
Comités de Ética de la Investigación. Los Seres Humanos. Investigación. Resoluciones.
topic pesquisa
Research Ethics Comitees. Humans Being. Research. Resolutions
Comités de Ética de la Investigación. Los Seres Humanos. Investigación. Resoluciones.
description The aim of this article is to discuss the role of the Ethics in Research and its responsibility for the adoption of future health policies. First, we present the institutional, functional and organizational characteristics of the system CEP / CONEP established by Resolution no. 196/1996 CNS and subsequently the changes suffered as a result of the approval of Resolution no. 466/2012 and no. 510/2016 also from CNS and its national influences. To this end, we investigate its legal guidelines, combined with the Single Health System (SUS), evaluating the use of technical-scientific language. Finally, the importance of including expert opinions on research involving human subjects, as those responsible for the affirmation of brazilian health law, analyzing the controversial court case involving the local population of Amapá state, which has become known as "human guinea pigs". We concluded, following which the Research Ethics Committee is the organization responsible for the future of the health system, precisely by established institutional communications when the authorization of such studies involving human subjects.
publishDate 2016
dc.date.none.fl_str_mv 2016-09-30
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/299
10.17566/ciads.v5i3.299
url https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/299
identifier_str_mv 10.17566/ciads.v5i3.299
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/299/393
dc.rights.driver.fl_str_mv Copyright (c) 2016 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIO
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2016 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIO
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
dc.source.none.fl_str_mv Iberoamerican Journal of Health Law; Vol. 5 No. 3 (2016): (JUL/SET.2016); 10-30
Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 5 Núm. 3 (2016): (JUL/SET.2016); 10-30
Cadernos Ibero-Americanos de Direito Sanitário; v. 5 n. 3 (2016): (JUL/SET.2016); 10-30
2358-1824
2317-8396
10.17566/ciads.v5i3
reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)
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reponame_str Cadernos Ibero-Americanos de Direito Sanitário (Online)
collection Cadernos Ibero-Americanos de Direito Sanitário (Online)
repository.name.fl_str_mv Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos.direitosanitario@fiocruz.br
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